Antibiotic Susceptibility Testing Disc Recall Due to Accuracy Concerns
BD BBL Sensi Disc Chloramphenicol test discs may have accuracy and quality control failures during antibiotic susceptibility testing. This could cause delayed results or inappropriate antibiotic selections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving diagnostic inaccuracy with potential for adverse diagnostic outcomes. No illnesses or injuries have been reported; the hazard is theoretical. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Chloramphenicol-30 ug, a diagnostic product used for in vitro antibiotic susceptibility testing. The recall encompasses approximately 2.3 million units across multiple lot numbers, distributed nationwide and internationally.
The discs may have reproducibility, accuracy, and quality control failures during antibiotic susceptibility testing for H. influenzae. These failures could cause product discard, delayed test results, or inaccurate diagnostic outcomes.
Potential adverse effects include diagnostic delays, selection of inappropriate antibiotics, or extended duration of antibiotic exposure during the treatment process. Clinical laboratories and healthcare facilities using affected product lots should be aware of this Class II recall.
The recalled product
- Product
- BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- qc-failure
- diagnostic-inaccuracy
- diagnostic-delay
- treatment-error
Distribution
Distributed nationwide across the United States.
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